Micro-osteoperforations and Tooth Movement: A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- 3D Digital Model Measurements of Canine Rate of Tooth Movement
研究概览
简要总结
The purpose of this study is determine the effect the Microosteoperforation (MOPs) using the miniscrew on the rate tooth movement. Moreover, measurement of the level of the pain and pain's interference, the level of satisfaction and comfort using this protocol. Finally root resorption associate with this technique will be evaluated.
详细描述
This study will be randomized, split mouth design controlled trial with a 1:1 allocation ratio. One resident (A.A), calibrated by the main supervisor (S.M), will be reliable for recruiting the subjects, undertaking the orthodontic treatment under the supervision. The eligibility of the cases will be reevaluated by main supervisor (E.M) before the start of treatment.
Split mouth design will be utilized with MOPs that will be randomly assigned to the patients' left or right sides to eliminate the possibility of uneven occlusal forces because of habitual occlusion predominantly on 1 side and also the eliminate the biological variability between subjects. The allocation sequence will be concealed from the researcher (A.A) enrolling and assessing participants in sequentially numbered, opaque, sealed and stapled envelopes with the participant's the name and date of birth are written before the intervention. Allocation concealment seeks to prevent selection bias, protects the assignment sequence until allocation.
A Ethical approval will be granted by Jordan University of science and technology research center, and permission will be given at postgraduate dental clinics at Jordan University of science and technology, Irbid, Jordan.
We hypothesized that 50% increased in rate of tooth movement in MOP group would produce a clinically significant difference. The sample size was calculated depend on a type I error frequency of 5%. According to the power analysis and assuming a large effect size difference between groups with 50% of acceleration rate of tooth movement, the power analysis yields a total sample size estimate of 44 samples at a conventional alpha-level (p = 0.05) and desired power (1 - β err prob) of 0.90, yielding 22 samples per group (means 22 patients that represent 22 MOP group and 22 Control group). Assuming an overall attrition rate of 15%, initial recruitment should target a total of 55 samples with 18 patients per group. All calculations were performed with the computer application G-Power (Erdfelder et al., 1996)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 26 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female
- •between 16 to 26 years old
- •Class II Division 1 malocclusion or bimaxillary protrusion
- •Average Lower facial height and Mandibular plane angle
- •No systemic disease
- •Healthy periodontal condition
- •Non smoker
- •Probing depth less than 4 mm in all teeth
排除标准
- •Long-term use of any Medication
- •Poor oral hygiene
- •Low and high angle cases
- •Systemic disease
- •Evidence of bone loss
- •Active periodontal disease
- •Probing depth more than 4 mm in all teeth
- •Cephalometric analysis of the included subjects was performed at baseline including
- •Sella-Nasion to A Point Angle (SNA): Measure Description: Sella-Nasion-A point (SNA) indicates the horizontal position of the maxilla relative to the cranial base.
- •Sella-Nasion to B Point Angle (SNB): Sella-Nasion-B point (SNB) indicates the horizontal position of the mandible relative to the cranial base.
- •A point to B Point Angle (ANB): A point- Nasion-B point (ANB) indicates the skeletal relationship between the maxilla and mandible.
- •Maxillary mandibular plane angle (MM): The angle formed between the Maxillary Plane and Mandibular Plane. Maxillary Plane is the plane demonstrated by a line through the anterior and posterior nasal spines.A mandibular plane is a plane demonstrated by a line through the gonion and menton.
- •Lower anterior facial height(LAFH)
- •Upper incisor inclination: The angle between the maxillary plane and the axis of the maxillary incisors.
结局指标
主要结局
3D Digital Model Measurements of Canine Rate of Tooth Movement
时间窗: Baseline to 3rd month
The baseline 3D digital model was superimposed to 3D digital models of 3rd month to determine the anterioposterior displacement of canines.
Intra Oral Measurements of Canine Rate of Tooth Movement
时间窗: Baseline to 3 month
Direct intraoral measurement of the distance between canine and second premolar in the patient's mouth was done every week using a digital caliper, from the upper mesial wing of the canine bracket to upper distal wing of second premolar bracket in both right and left sides parallel to the occlusal plane for 3 months.
次要结局
- Pain Intensity(within 7 days after the intervention)
- Root Resorption(Baseline to 3rd month)
- Pain Interference /Pain During Eating?(within 7 days after the intervention)
- Pain Interference /Pain Interrupted Sleep(within 7 days after the intervention)
- Pain Interference /Swelling of the Surgical Side(within 7 days after the intervention)
- Patient Satisfaction(After 7 days of MOP application)
- Menstrual Cycle(within 3 months)
- Pain Interference /Discomfort(within 7 days after the intervention)
研究者
Amal Alkebsi
MClindent in Orthodontics, Department of Preventive Dentistry, Faculty of Dentistry
Jordan University of Science and Technology